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IRCT20220424054633N1 IRCT 2022-06-06 Tehran University of Medical Sciences The efficacy assessment of Silversulfadiazine topical cream containing Epidermal growth factor (EGF) on burn wounds healing (type II) ‍Comparison of efficacy of Silversulfadiazine topical cream containing Epidermal growth factor (EGF) and Silversulfadiazine topical cream without Epidermal growth factor (EGF) on burn wounds healing (type II). 2022-06-10 anticipated 35 Complete https://irct.ir/trial/63204 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Two areas of each participant's burn site are randomly assigned as area one and area two. Since the study is double blind the physician chooses the burn areas by simple randomization.The creams of the intervention group and the control group are prepared by one of the project partners for each person and are given to the patient as one and two, to use cream one in area one and cream two in area two, Blinding description: The coding is done by the project epidemiologist. The doctor receives the creams labeled with numbers 1 or 2, and by simple randomization, considers one area as area one, and prescribes cream number one, and considers the other area as area number 2 and prescribes cream number two. The doctor gives the patient additional information on how to use the creams. The patient also receives labeled creams that are similar in color and texture. The method of using both creams is the same, only for area one, cream number one and for area number 2, cream number 2 is used. The evaluator who evaluates the burn site at the beginning of the study and then at the end of the first, second, third and fourth weeks and collects the data also is not aware of coding system. The doctor, the evaluator and the patient are blind. The patient receives the coded drug (intervention or control). The data analyzer who drafts the article knows is aware of the coding. 3 Grade II burn wounds. Intervention 1: Intervention group: Silver Sulfadiazine 1% containing 0.001% Epidermal Growth Factor topical cream was used and the burn wound area is covered by sterile gauze, very 12 hours wound area is cleaned by normal saline and bandaged. Intervention 2: Control group: Silver Sulfadiazine 1% topical cream was used and the burn wound area is covered by sterile gauze, every 12 hours wound area is cleaned by normal saline and bandaged. In fact the control group receives the standard treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Privacy control
public Majid Golkar
No. 69, Pasteur St., Tehran
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6411 2267 majid.golkar@gmail.com Pasture Institute of Iran scientific Majid Golkar
Np.69, Pasteur St. Tehran
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6411 2267 majid.golkar@gmail.com Pasture Institute of Iran Iran (Islamic Republic of) People with grade II burn wounds. Burn area must be bilateral, in 2 hands or 2 legs, etc. 18 years 60 years Both Having any underlying diseases that interfere with wound healing such as chronic kidney disease, diabetes, liver disease, any diseases of immunodeficiency, and smoking. Having cancer or background of Cancer Allergy to Epidermal Growth Factor, silver sulfadiazin or any material in the formulation. Pregnancy Breastfeeding T29.2 Burns of multiple regions, no more than second-degree burns mentioned Treatment - Drugs Treatment - Drugs Intervention group: Silver Sulfadiazine 1% containing 0.001% Epidermal Growth Factor topical cream was used and the burn wound area is covered by sterile gauze, very 12 hours wound area is cleaned by normal saline and bandaged. Control group: Silver Sulfadiazine 1% topical cream was used and the burn wound area is covered by sterile gauze, every 12 hours wound area is cleaned by normal saline and bandaged. In fact the control group receives the standard treatment. Wound size. Timepoint: At the beginning of the study (Before intervention), end of first week, end of second week, end of third week, end of fourth week. Method of measurement: Photography and Image J software. Epidermis Thickness. Timepoint: At the beginning of the study (Before intervention), end of first week, end of second week, end of third week, end of fourth week. Method of measurement: Biometry. Dermis Thickness. Timepoint: At the beginning of the study (Before intervention), end of the first week, end of the second week, end of the third week, end of the fourth week. Method of measurement: Biometry. Wound healing velocity. Timepoint: At the beginning of the study (Before intervention), end of the first week, end of the second week, end of the third week, end of the fourth week. Method of measurement: Photography and Image J software. Improving Life's Quality. Timepoint: َAt the beginning of the study and two week after finishing the study. Method of measurement: Interviewing and giving out self assessment form. Borna Biopharma Science based Co. Tehran University of Medical Sciences Borna Biopharma Science based Co. Approved 2022-03-16 Research Ethics Committees of School of Medicine - Tehran University of Medical Sciences Research ethics committees of school of medicine- Tehran university of medical sciences. Qods street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)